Kornimate/medical-research-clean huggingface dataset:
safety of microporous annealed particle (map) wound matrix in patients with clean surgical wounds.

Conditions: Wound Heal

Summary: a randomized, open-label, investigational safety evaluation of the microporous annealed particle (map) wound matrix (tt101) device as a volumetric biomaterial scaffold applied to clean wounds after skin cancer surgery with mohs micrographic surgery (mms) compared to control.


Eligibility criteria:
inclusion criteria: * willing to undergo the written informed consent process prior to enrollment in this study. * at least 22 years of age at screening. * has non-melanoma skin cancer and be scheduled for skin cancer surgery with mohs micrographic surgery on a location suitable for secondary intention healing. * resulting surgical wound after mohs micrographic surgery must be at least 1 cm and no more than 4 cm in diameter (or surface area of at least 0.8 cm2 and no more than 12.6 cm2). * resulting surgical wound after mohs micrographic surgery must be full thickness. * willing to return for all required follow-up visits. * willing to follow the instructions of the principal investigator. exclusion criteria: _ has a confirmed diagnosis of clinically significant peripheral neuropathy. * has uncontrolled type i or type ii diabetes and hba1c values greater than 8.0% within the last 6 months. * has a known infection in the area of the mohs micrographic surgery. * has a known allergy to any of the components of the tt101 device. * is an active daily cigarette smoker. * is pregnant or lactating. * is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; iud; or surgical sterilization of partner). * has clinical evidence of peripheral vascular disease (pvd) in the form of grade 2 pitting edema or higher. * has been diagnosed with a surgical or wound site infection within the last 6-months. * has been diagnosed with chronic ulcer or wound within the last 12- months. * has a remote active infection concurrent with having the mohs micrographic surgery. * per investigator's discretion the subject is not appropriate for inclusion in the trial.
impella supported opcabg

Conditions: Ischemic Cardiomyopathy

Summary: the present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (lvad) to minimize myocardial injury and eliminate low output state during the perioperative period


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * ejection fraction ≤ 35% * symptomatic three vessel coronary artery disease with target vessels that are amenable to bypass (as determined by the operating surgeon) or left main disease * adequate distal target caliber (as determined by the pi or operating surgeon) exclusion criteria: * exclusion criteria will include the existing contraindications to either impella therapy or opcabg revascularization: * patients with structural heart disease requiring cardiopulmonary bypass * patients with cardiogenic shock who require a period of short-term mechanical circulatory support * patients with mechanical aortic valve * patients with previous median sternotomy * patients with evidence of non-viability on preoperative cardiac mri or ct scan * insufficient conduit * bmi over 50 * suspected or known pregnancy
a human volunteer study investigating single oral doses of gsk598809 in otherwise healthy smokers

Conditions: Substance Dependence

Summary: study to investigate the safety, tolerability and pharmacokinetics of gsk598809 in otherwise healthy volunteers. this study is required because this drug is being developed for the treatment of nicotine dependence. it is important to evaluate how this drug interacts in healthy smokers. the study is planned to consist of a single part, with 4 dosing periods. subjects will receive 3 escalating doses of gsk598809 and 1 dose of placebo. there will be at least 1 week of wash out between doses. in each dosing period 14 subjects will receive escalating doses and 4 subjects will receive placebo. the actual doses used will be determined based on the safety/ tolerability and pharmacokinetics during the previous dose. it is expected that the duration of this study will be approximately 10 weeks.


Eligibility criteria:
inclusion: * a healthy man or woman * 18 - 50 years old * neither too fat, nor too thin * female subjects must use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up visit. * female subjects must not be breast feeding and should not have been breast feeding for a month. * male subjects must agree to use an acceptable method of contraception from the first dose of study medication until 90 days following the final follow-up. * subjects need to smoke 20 - 40 cigarettes a day inclusive for at least the past year and to not have tried to quit in the 3 months before the start of the study. exclusion: * any current medical or psychiatric illness * any history of chronic medical or psychiatric illnesses * previous or current alcohol or drug abuse/dependence including nicotine * personal or family history of prolonged qtc syndrome

Keywords: tolerability dose escalation gsk598809 pharmacodynamics safety single placebo smokers pharmacokinetics
improvement of foodallergy diagnostic in gastrointestinal tract

Conditions: Food Allergy

Summary: currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal tract are scarce. the endoscopic segmental lavage is the method of choice, but it´s controversial. additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the mucosa cells and biopsies are taken. comparative to the lavage specific ige antibodies, tumor necrosis factor- alpha, eosinophilic cation protein and mastcell tryptase were measured.


Eligibility criteria:
inclusion criteria: * all patients with suspicion of food intolerance and confirmed food allergy exclusion criteria: * pregnant and patients under allergy medication (antihistaminic, cortison)
transcutaneous electric nerve stimulation in sleep of patients with parkinson's disease

Conditions: Parkinson Disease

Summary: sleep disorders are among the non-motor signs more common in parkinson's disease (pd). this case series evaluated the effects of transcutaneous electrical nerve stimulation (tens) on acupoints in the self-assessment of sleep in 14 pd patients classified between stages 1 and 3 of hoehn and yahr original (hy). patients were assessed using the sleep scale for parkinson's disease (pdss) and subjected to treatment with eight tens sessions on acupoints, with the current burst. we used the paired sample t-test, considering p ≤ 0.05.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of idiopathic pd between stages 1 and 3 according to the original version of the hoehn \& yahr (hy) scale exclusion criteria: * patients with mini mental state examination (mmse) lower than 18 points, with other associated neurological diseases and on medication for depression, anxiety, psychosis and sleep inducers.
report of a new method used to identify the bacteria present in a human colon biopsy sample

Conditions: Molecular Analysis

Summary: the method used for the biopsy analysis may be able to provide important insights into the complex microbial communities found in the human colon or in complex human infections. therefore, this methodology may prove useful to other researchers or physicians.

the method used to identify the microbes in the sample was chosen because it had the potential to provide more exhaustive identification of the bacteria present in the sample as compared to culturing methodology. the molecular method worked well, so it is appropriate to share the method with the medical and scientific communities.

Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis * age \>= 18 years old * female exclusion criteria: anyone not meeting inclusion criteria.

Keywords: ulcerative colitis (uc)
anterior prolapse repair with and without graft augmentation

Conditions: Pelvic Organ Prolapse

Summary: this is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (arcus) to anterior colporrhaphy with a suture-based repair (native tissue). patients were randomized to one treatment and then were followed post-operatively for 7-10 years. prior to surgery patients had a popq vaginal prolapse exam and completed a quality of life questionaire (pfdi). they had a repeat popq exam and quality of life questionaires at their post-op operative visits. we compare recurrent prolapse rates between these 2 groups.

objective: to determine whether dermal allograft (arcus) reduces anterior prolapse recurrence at 1 and 7-10 years post-operatively. our central question is whether we can reduce the rate of rate of anterior compartment prolapse recurrence after surgical repair, is the recurrence rate reduced with allograft use, and does this benefit hold up over time? methods: patient will be randomized by computer generated block randomization to native tissue (suture based) anterior colporrhaphy or colporrhaphy with graft (arcus) usage. neither patients nor surgeons will be blinded due to the nature of the surgery. patients will be followed for 7-10 years post-operatively. participants will complete a popq exam and the pfdi (pelvic floor distress inventory) questionnaire pre-operatively. patients will return for a popq exam at 1 year post-operatively and complete the pfdi (pelvic floor distress inventory) and pisq (sexual function for women with: pop, urinary incontinence and/or fecal incontinence) questionnaires. patients will be asked to return to the office for a research visit 7-10 years post-operatively for a popq exam and to complete quality of life questionnaires including pfdi 20 (pelvic floor distress inventory), pisq-r (sexual function for women with: pop, urinary incontinence and/or fecal incontinence, revised), and pgi (patient global assessment of improvement).

Eligibility criteria:
inclusion criteria: any patient planning to undergo surgery for anterior compartment prolapse, english speaking. - exclusion criteria: any patient who does not speak english due to standardized english language based questionaires, and patients without anterior compartment prolapse. -

Keywords: pelvic organ prolapse, vaginal graft
technology based sedentary reduction intervention in patients with type 2 diabetes

Conditions: Type 2 Diabetes; Sedentary Behavior; Physical Activity

Summary: the purpose of this study is to develop and test an 8-week sedentary behavior reduction intervention ("sit less" program) for patients with type 2 diabetes. the program aims to reduce and break sitting times among this population using an objective activity monitor and mhealth. the investigators will test the program to help diabetes patients break up sitting time, reduce daily sitting time, and move more. the investigators will also study preliminary effects of the sb reduction intervention on light physical activity, cardiometabolic markers and patient-centered outcomes, and whether diabetes patients like the program and can follow it.

the investigators propose to develop and conduct a pilot study to test a wearable technology-based sedentary behavior reduction intervention in type 2 diabetes patients. the participants in the first cohort (n=15), 'sit less version 1' will be randomized to either the control group or the sedentary behavior reduction intervention group. the intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mhealth. the study will have an iterative design process with multiple cohorts. after the first cohort completed the study, we will collect their feedback to modify the sit less program. with sit less version 2, cohort 2 (n=20) participants will participate in the intervention as a single group, without randomization. the sit less version 2 will be 8 weeks long. specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in type 2 diabetes patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.

Eligibility criteria:
inclusion criteria: * ages 18 and above * diagnosed with type 2 diabetes * self-reported hba1c\<13 * self-report of sitting ≥ 8hr/day * ability to stand and walk * ownership of a smartphone. exclusion criteria: * currently using an activity tracker * use of insulin * random blood glucose \>300 * currently participating in exercise or other research programs * non-english speaking * patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking * currently pregnant
a clinical trial to evaluate the effectiveness of an acne serum in improving facial acne and post-acne pigmentation

Conditions: Acne

Summary: this study will evaluate the efficacy of the rael miracle clear complete acne serum product in improving facial acne and post-acne pigmentation. this study will last for 56 days. the study will be conducted as a single-arm trial where all participants will use the test products. participants will be required to complete questionnaires at baseline, day 1, day 3, day 7, day 14, day 28, and day 56. photos will be taken at baseline, day 28, and day 56. the photos from baseline and day 56 will undergo expert skin grading


Eligibility criteria:
inclusion criteria: * female. age 18+. currently experiencing mild to moderate acne issues. generally healthy -and not living with any uncontrolled chronic disease. exclusion criteria: * anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders. anyone currently using an oral and/or topical prescription acne treatment. anyone unwilling to stop using their current acne supplements. anyone with known severe allergic reactions. anyone unwilling to avoid excessive sun exposure. anyone who is breastfeeding, pregnant, or attempting to become pregnant. anyone unwilling to follow the study protocol. anyone who identifies as having sensitive skin.
laparoscopic sacrocolpexy versus lateral suspension

Conditions: Pelvic Organ Prolapse

Summary: surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal vault. most of studies shows a success rate of 80% of this procedure. however, access to the promontory could be difficult in patients because of adherences or anatomical reasons. this step of the procedure also exposes to risk of ureteral or vascular injuries. recent issues have also found spondylodiscitis cases. the technique of laparoscopic lateral suspension with mesh was developed by dubuisson in 1998 allows not to have to approach the promontory and avoids both the risk of vascular injury and ureteral damage of laparoscopic sacrocolpopexy. instead of attach the mesh to the promontory, the procedure consists in spreading out bilaterally, a subperitoneal t-shaped mesh in the anterior abdominal wall. the aim of this study is to compare the clinical and functional efficiency of the lateral suspension versus laparoscopic sacrocolpopexy. it is a prospective, randomized, monocentric study compared two groups the study hypothesis is that the lateral suspension would provide correction than the laparoscopic sacrocolpopexy. the primary outcome is the comparison of anatomic correction rates at 1 year success is defined as 1 year ba et c points \< -1 centimeter in pop-q international score. secondary endpoints are improve of quality of life evaluated with the validated p-qol questionnaire, and complications rates, including post-operative posterior prolapse. number of subjects required is 72 patients, 36 in each group having a laparoscopic sacrocolpopexy or lateral suspension. outcomes will be evaluated at 1 month and 1 year post-operative consultation


Eligibility criteria:
inclusion criteria: * patients at least 18 years old. * patients who agreed to participate in the study and signed informed consent. * patient affiliated to a social protection system. * surgical indication by laparoscopy of prolapse cure symptomatic of the anterior stage and / or isolated medium. exclusion criteria: * minor patient. * patient refusing to sign the consent or unable to receive the necessary information to give informed consent. * patient not affiliated to a social protection system. * presence of one or more contraindication (s) to laparoscopy * presence of posterior prolapse requiring surgical treatment * need for an associated surgical procedure. * major people under legal protection
pegs for osteofixation of proximal humeral fractures

Conditions: Implant Complication; Proximal Humeral Fracture; Avascular Necrosis of Humerus

Summary: patients treated operative for proximal humeral fractures with angular stable device (philos plate or alps-php)

from a cohort of patients treated for displaced proximal humeral fractures (phf) in the period july 2017 - august 2019 patients with the 11-b2 and 11-c2 phf according to ao/ota 2007 fracture classification were selected according to age and gender to be compared with patients operated with a philos plate within the same fracture group, age and gender to be matched for adverse events: 1. radiographic evidence of penetration of pegs (alps-php) or screws (philos) into the glenohumeral joint (primary outcome) and 2. avascular head necrosis / sinking / need of re-surgery 3. clinical proms

Eligibility criteria:
inclusion criterion: * acute proximal humeral fracture * ao/ota type 11-b2 or 11c2 exclusion criteria: * not eligible to surgical treatment * non-compliant * former shoulder fracture or symptomatic shoulder illness * drug abuser

Keywords: humeral head screw penetration peg penetration avascular necrosis
tens for endometriosis pain in adolescents and young adults

Conditions: Endometriosis (Diagnosis)

Summary: the goal of this project is plan to investigate the utility of transcutaneous electrical nerve stimulators (tens) for the reduction of pain and the improvement of quality of life in adolescents and young adults with chronic pelvic pain related to endometriosis.


Eligibility criteria:
inclusion criteria: * adolescent girls and young women (13-25) * diagnosis of endometriosis, * current pelvic pain (score ≥ 3 on visual analog scale, where 0 represents absence of pain and 10 indicates unbearable pain) present for ≥ 14 days/month over the 2 months prior to study enrollment. * personal smart phone or mobile device * speak either english or spanish.

Keywords: endometriosis tens transcutaneous electrical nerve stimulation
a ketogenic diet acts on cortical but not subcortical responsivity in migraineurs

Conditions: Migraine Disorders

Summary: a short ketogenic diet (kd) treatment can prevent migraine attacks and correct excessive cortical response. here, investigators aim to prove if the kd-related changes of cortical excitability are primarily due to cerebral cortex activity or are modulated by the brainstem. through the stimulation of the right supraorbital division of the trigeminal nerve, there will be concurrently interictally recorded the nociceptive blink reflex (nbr) and the pain-related evoked potentials (prep) in 18 migraineurs patients without aura before and after 1-month on kd, while in metabolic ketosis. nbr and prep reflect distinct brain structures activation: the brainstem and the cerebral cortex respectively. it will be estimated nbr r2 component area-under-the-curve as well as prep amplitude habituation as the slope of the linear regression between the 1st and the 2nd block of 5 averaged responses.


Eligibility criteria:
inclusion criteria: * diagnosis of migraine * kept a headache diary for at least 1 month * headache onset before the age of 50 exclusion criteria: * over consumption of acute pain-killers (triptan, analgesic, or ergotamine) * pregnancy or lactation * type i diabetes * serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation.

Keywords: ketogenic diet
surgery with or without chemotherapy in treating patients with stage i non-small cell lung cancer

Conditions: Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Bronchoalveolar Cell Lung Cancer; Large Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer

Summary: randomized phase iii trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage i non-small cell lung cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. it is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

primary objectives: i. to determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage i patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a t2n0 tumor (according to the criteria of the international staging system for lung cancer). secondary objectives: i to compare failure-free survival of patients with t2n0 stage i nsclc who have and have not been treated with adjuvant chemotherapy. ii. to determine the toxicities associated with adjuvant chemotherapy. iii. to describe the pattern of disease recurrence. outline: this is a randomized, multicenter study. patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms. arm i:patients receive no further therapy. arm ii: patients receive adjuvant therapy comprising paclitaxel iv over 3 hours followed by carboplatin iv over 1-2 hours on day 1. treatment continues every 3 weeks for 4 courses. patients are followed every 4 months for 2 years and then every 6 months thereafter.

Eligibility criteria:
inclusion criteria: * histologically documented non-small cell carcinoma * completely resected t2n0m0 stage i nsclc as defined by the international staging system * surgery shall consist of a lobectomy or pneumonectomy with resection of associated n1 lymph nodes (either by thoracotomy or thoracoscopy) * patients must be randomized within 4 to 8 weeks from the date of complete surgical resection * no prior chemotherapy or radiation for non-small cell lung cancer * performance status of 0 or 1 * women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study * patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years * granulocytes \>= 1,800/ul * platelets \>= 100,000/ul * bilirubin \< 1.5 mg/dl * sgot (ast) \< 2.0 x uln